The role of Ifosfamide Etoposide rechallenge in recurrent relapsed Ewings Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Objective Response Rate (Complete response plus Partial Response) Rates
研究概览
简要总结
Background :
Recurrent/relapsed Ewing’s sarcoma has a poor outcome, especially patients with systemic relapse. Multiple regimens are used at progression, but none have been established as the standard of care. According to a recent ongoing, randomised trial, High dose ifosfamide was found to perform better in terms of a better survival, albeit with higher toxicity rates and treatment discontinuation. The intent of the treatment in a recurrent setting is palliative, and should take into account the side effects. Ifosfamide-etoposide rechallenge, after a treatment free interval is an option, which may be safe and effective, and improve the quality of life of these patients. IE is an established part of treatment in the first line setting, especially for non-metastatic ewing’s, however, there is no data regarding its use in the second line setting, especially in patients who have received VAC/IE in the first line setting. The current study will be done to assess the efficacy and safety of this combination in the indian population.
Methodology
The total sample size will be 42. Patients after an informed consent, Age of 5 to 50 years with Histologically proven Ewing’s sarcoma at initial diagnosis or recurrence with Distant, combined (local plus distant) relapse or isolated local recurrence which is unresectable upfront and with a Treatment free interval with Ifosfamide and etoposide more than 12 months , progressing after one or more lines of chemotherapy with ECOG PS 0-2, and acceptable lab parameters as defined in the inclusion and exclusion criteria will be recruited. They will receive Ifosfamide etoposide every 21 days, with dose modification based on severity of toxicities, according to the mentioned criteria.
Outcomes
Primary endpoint is the Objective Response rate, which will be based on response assessment with repeat Imaging, defined according to the RECIST criteria. Secondary outcomes to be evaluated, include, Duration of Response, Progression Free Rate at 3 months, quality of life and Side effect Profile. Patients with response to the chemotherapy will be given a total of 6 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Month(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent Age of 5 to 50 years Histologically proven Ewing’s sarcoma at initial diagnosis or recurrence Distant or combined (local plus distant) relapse Exposure to Ifosfamideand etoposide more than 12 months ago Progression after atleast one line of treatment ECOG PS 0-2 ANC more than 1000 per microlitre Hemoglobin more than 8 g per dL Platelet more than 1 lac per microlitre Creatinine less than 1.5 times ULN eGFR more than 30ml per min (Cockcroft-Gault) Total bilirubin less than 5 times ULN ALT and AST less than 5 times ULN, alkaline phosphatase less than 2.5 times ULN.
排除标准
- •Cytotoxic chemotherapy within 2 weeks Radiation therapy within 6 weeks Active or uncontrolled infection Isolated local recurrence amenable to curative surgical resection Previous CTCAE v.5 grade 3 or 4 acute kidney injury / encephalopathy or neurotoxicity / myelosuppression due to prior ifosfamide or etoposide treatment Active heart disease, uncontrolled hypertension and arterial or venous thrombotic disease Pregnant or breastfeeding patient.
结局指标
主要结局
Objective Response Rate (Complete response plus Partial Response) Rates
时间窗: 3 months
次要结局
- Duration of Response(Progression Free Rate at 3 months)
研究者
Dr Anand Shahi
All India Institute Of Medical Sciences, New Delhi